UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061664 |
|---|---|
| Receipt number | R000068703 |
| Scientific Title | ENtire ABLation rEgistry of Osaka CardioVascular Conference: ENABLE-OCVC |
| Date of disclosure of the study information | 2026/05/25 |
| Last modified on | 2026/05/22 17:45:29 |
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Basic information
Public title
ENtire ABLation rEgistry of Osaka CardioVascular Conference: ENABLE-OCVC
Acronym
ENABLE-OCVC registry
Scientific Title
ENtire ABLation rEgistry of Osaka CardioVascular Conference: ENABLE-OCVC
Scientific Title:Acronym
ENABLE-OCVC registry
Region
| Japan |
Condition
Condition
Arrhythmia
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Catheter ablation (CA), which has become indispensable as a therapeutic option for cardiac arrhythmias, continues to evolve in response to advances in adjunctive technologies and progress in understanding arrhythmia pathophysiology. We will establish a large-scale, multicenter database to continuously update and refine optimal treatment strategies.
Using long-term, large-scale multicenter data, we will comprehensively analyze patient characteristics, indices for pathophysiological assessment, and prognostic information to:
1. continuously pursue optimal treatment strategies;
2. examine the relationships between patient factors, ablation outcomes, and prognosis; and
3. collect clinical data to facilitate the societal implementation of medical informatics and artificial intelligence technologies.
Through these multifaceted, long-term investigations, we aim to generate insights that will contribute to earlier diagnosis and detection and to improved prognosis for patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Recurrence within 3 years after catheter ablation
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All patients who underwent catheter ablation at the participating institutions
Key exclusion criteria
Patients who decline participation in the study (opt out).
Patients deemed unsuitable for inclusion by the principal investigator or co-investigators for any reason.
Target sample size
8000
Research contact person
Name of lead principal investigator
| 1st name | Yasushi |
| Middle name | |
| Last name | Sakata |
Organization
The University of Osaka Graduate School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
565-0871
Address
2-2 Yamadaoka, Suita, Osaka
TEL
06-6879-3631
yasushisk@cardiology.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Yohei |
| Middle name | |
| Last name | Sotomi |
Organization
The University of Osaka Graduate School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
565-0871
Address
2-2 Yamadaoka, Suita, Osaka
TEL
06-6879-3631
Homepage URL
ocvc.hf@gmail.com
Sponsor or person
Institute
The university of Osaka
Institute
Department
Personal name
Funding Source
Organization
The university of Osaka
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The University of Osaka Hospital Ethical Review Board
Address
2-2 Yamadaoka, Suita, Osaka
Tel
06-6879-5111
rinri@hp-crc.med.osaka-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
大阪府
Institutions
Institutions
大阪大学医学部附属病院、独立行政法人 労働者健康安全機構 大阪ろうさい病院、地方独立行政法人 市立東大阪医療センター、社会医療法人 大阪国際メディカル&サイエンスセンター 大阪けいさつ病院、独立行政法人 労働者健康安全機構 関西ろうさい病院、地方独立行政法人大阪府立病院機構 大阪急性期・総合医療センター、独立行政法人 地域医療機能推進機構 大阪病院、独立行政法人 国立病院機構 大阪医療センター、地方独立行政法人 りんくう総合医療センター、八尾市立病院、医療法人渡辺医学会 桜橋渡辺未来医療病院
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 05 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2025 | Year | 08 | Month | 19 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2026 | Year | 05 | Month | 22 | Day |
Last follow-up date
| 2031 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Arrhythmia recurrence after catheter ablation will be assessed as the primary endpoint.
Management information
Registered date
| 2026 | Year | 05 | Month | 22 | Day |
Last modified on
| 2026 | Year | 05 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068703
